by Dr. Yashashwini Reddy | Sep 19, 2024
Japan’s new drug approval process is managed by the Pharmaceuticals and Medical Devices Agency (PMDA), which works under the Ministry of Health, Labour, and Welfare (MHLW). Here’s an overview of how a drug gets approved in Japan: 1. Preclinical Testing...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
by Dr. Yashashwini Reddy | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
by Dr. Yashashwini Reddy | Jun 14, 2024
Global expedited regulatory pathways are processes crafted to speed up new drug approval and availability across different countries. These include drugs, vaccines, and medical devices. These pathways aim to bring the new drugs as fast as possible by fastening the...
by Dr. Yashashwini Reddy | Jun 4, 2024
In this article, you are going to learn about the regulatory procedure for combination products in the US. What is RFD what are the timelines for it and what role of the Office of Combination products? Combination products as discussed in the article are medicinal...
